http://www.yourlawyer.com/topics/overview/st_jude_aortic_connector Sat, 21 Nov 2009 21:05:35 -0800 pixel-app en http://www.yourlawyer.com/articles/read/16753 Thu, 16 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16753 Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in Texas.   According to The Wall Street Journal, the lawsuits were filed by former employees of the companies.

Allegations of kickbacks by medical device makers are nothing new.  For example, in 2007 a New Jersey based federal probe found  that some orthopedic device makers made lucrative payments to U.S. physicians  between 2002 and 2006 as a way to encourage doctors to favor their products. Stryker Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

The lawsuits detailed by The Wall Street Journal, which were filed in federal court in Houston, are related to an inquiry in Texas by the U.S. Justice Department that was previously disclosed by several of the companies in filings with the Securities and Exchange Commission.  They were originally filed in 2007, the Journal said.

According to the Journal, the lawsuits allege that a "fraudulent marketing and inducement campaign" involving kickbacks to doctors and hospitals resulted in excessive charges to the Medicare insurance program.  For example, several of the suits allege that Boston Scientific, Medtronic and AtriCure marketed surgical ablation equipment as a treatment for atrial fibrillation even though it was not approved by the Food and Drug Administration to treat that condition.

Those charges were made by a former Boston Scientific salesperson, who the Journal says, claimed to have been fired after complaining about the company's allegedly illegal practices.

All of the companies involved in the lawsuits told The Wall Street Journal that they were cooperating with the probe.  Boston Scientific is no longer in the ablation business, the Journal said.

]]> http://www.yourlawyer.com/articles/read/16472 Thu, 23 Apr 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16472
The filing stated that the FDA inspected St. Jude Medical’s Atrial Fibrillation (AF) Division’s catheter facility on a number of occasions from December 8 and December 19 and notified St. Jude Medical on December 19 that it observed issues with the manufacture and assembly of its Safire ablation catheter, reported BizJournal, which fix irregular heartbeats and destroy damaged and diseased tissue with heat, explained the Associated Press (AP). The warning letter was issued last Friday, said the AP.

The FDA said it would not approve new devices for manufacture at the St. Jude Medical plant until the firm corrects the outstanding problems, said the AP, noting that faulty record keeping was among the problems cited.

Typically, catheter systems consist of an energy generator and an attachable catheter, which is used on the patient's tissue, said the AP.

This is not the first time St. Jude Medical has been the subject of controversy over its products. The St. Jude Symmetry Bypass Aortic Connector has been associated with a high occurrence of heart attacks, respiratory failure, and has been linked to several deaths, with adverse effects that include graft narrowing, valve leakage, failed deployment, and occlusion. The St. Jude Symmetry is commonly used in "beating heart" or "off machine" heart bypass surgery, which has gained in popularity because it eliminates the need for the patient to be connected to a lung machine during bypass surgery and enables thoracic surgeons to attach saphenous (leg) vein grafts to the aorta without sutures and without clamping the aorta during the procedure.

The St. Jude Medical Symmetry device was approved in 2001 after an abbreviated approval process; thousands of the devices have since been implanted in patients. Despite adverse reports, St. Jude Medical neither conducted clinical trials or testing of a larger segment of the post-cardiac bypass population, nor has it made any alterations in design or manufacture to lessen the great danger the connector poses to patients.

Also, St. Jude Medical said it identified a memory chip problem in some of its older implantable cardioverter defibrillators (ICDs) devices, which stems from a memory chip St. Jude Medical used through 2002 that is susceptible to background radiation. St. Jude Medical notified doctors and federal regulators of a software problem in some models of its ICDs that could cause the heart-shocking device to malfunction. About 39,000 patients are affected by this news.

ICDs are implanted devices the size of a stopwatch that are placed in the upper chest and shock or pace an irregular heart beat back into rhythm. In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the heart. The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. A second problem could cause a temporary increase in the device's pacing rate. In addition to its shocking therapy, some patients need an ICD that can pace their heart, as well.

]]> http://www.yourlawyer.com/articles/read/7386 Wed, 07 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7386
U.S. District Judge John Tunheim on Monday also reduced the number of potential plaintiffs in the lengthy lawsuit against the Little Canada-based medical device company.

The case involves St. Jude's Silzone heart valve, which was surgically implanted in about 36,000 people worldwide after receiving Food and Drug Administration approval in 1998. However, clinical trials done after the FDA approval determined that the Silzone valves were prone to leak.

In 2000, St. Jude voluntarily recalled all the Silzone valves that had not been implanted and told hospitals and doctors to quit using the product. The company also contacted patients with implanted Silzone valves and established a fund to pay for uninsured medical costs associated with any leaks. About 10,500 of the Silzone valves were implanted in U.S. patients.

Tunheim dismissed one class of patients seeking standing to sue St. Jude over the Silzone but also certified a class of patients from 13 states and the District of Columbia who received the valve.

Officials from St. Jude declined to comment on the ruling.

Nearly 40 federal cases have been consolidated in U.S. District Court in Minneapolis. Other cases nationwide were settled or dismissed. A similar class-action lawsuit is pending in Ontario, Canada.

Thomas Gunderson, an analyst at Piper Jaffray in Minneapolis, said St. Jude has $200 million in reserves to cover expenses from the Silzone.]]> http://www.yourlawyer.com/articles/read/6917 Wed, 24 Sep 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6917
Silzone mechanical heart valves, by St. Jude Medical, were coated in silver, the company says, to reduce the rate of infection in patients.

Three years after the company introduced them, they recalled the valves because they were making too many people sick.

Eric Anderson received Silzone heart valves in 1998, one of about 2,300 Canadians who were implanted with the devices between 1997 and 2000, the year the valves were recalled.

In Anderson's case, the sutures on one of the valves tore away from the heart muscles, causing a leak that made his heart work harder than it should have.

"It's a terrible feeling always to be scared that something can happen tomorrow," said Anderson.

St. Jude Medical has insisted that it acted responsibly, but the company now faces a class action lawsuit.

The lawyer for Anderson and others in the lawsuit, says the company was negligent in its research and development of the valve.

Anderson's attorney says the company should have known there would be problems with the valve before it sought approval from government regulators.

And he says the company vigorously marketed the product without proper testing.

Health Canada approved the Silzone valve in 1997, despite internal documents questioning the company's claim that the silver reduced infection rates.

A spokesman for St. Jude Medical said the company acted responsibly in recalling the valve.

"We did a voluntary recall of this valve back in January 2000 and we've been responding to claims from litigants and their attorneys since then," said Peter Gove.

Gove said the company opposes class action status because each patient's history and experience is different.

St. Jude has until next week to appeal the decision to allow the suit to go forward as a class action. ]]> http://www.yourlawyer.com/articles/read/6888 Sat, 30 Aug 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6888
The Minnesota based company, which is already the target of class action lawsuits over Silzone in the United States and Canada, is to be sued in London's High Court by Billy McCombe of Northern Ireland. Mr McCombe's wife, Myrtle, died in July 1998, aged 44, 10 weeks after receiving a Silzone mitral valve implant.

The Silzone valve is a variant of the standard St Jude valve, with a silver coating on the sewing cuff used for attachment. The silver was meant to discourage bacterial infection and reduce the rate of endocarditis, one of the most common and dangerous complications of artificial valve implantation. Silzone valves were approved in the United Kingdom in 1997.

About 37 000 Silzone valves were implanted worldwide, including about 1300 in the United Kingdom, 10 000 in the United States, and 2300 in Canada. Most of the rest were implanted in Europe.

Solicitors for Mr McCombe, say the device was not adequately studied before marketing. They also cite a confidential document, written by a member of St Jude's marketing advisory panel, that describes Europe as "the guinea pig continent."

Richard Meeran, a partner at Leigh, Day & Co, said: "It is hard to see how St Jude can defend this case. The Consumer Protection Act imposes strict liability on manufacturers. Many people in this country may potentially have been seriously harmed by this product."

Peter Gove, vice president of St. Jude Medical, told the BMJ that he believed that the British claim had less merit than lawsuits under way in the United States and Canada, where six provincial health ministries are among the plaintiffs. "Mrs McCombe had a thrombus, which is a risk associated with all heart implants and all heart surgery. The Canadian and American suits concern paravalvular leak, which was the problem identified in the AVERT study we commissioned to monitor this device in the patient population."

In the AVERT study, eight patients in the Silzone treatment arm had to have their implant removed because of paravalvular leak, compared with one patient in the group using standard St Jude valves. In January 2000, the study's independent board suspended further enrolment. The company issued a recall of valves that had not yet been implanted. Patients with implanted valves have been advised to keep them.

Other problems have been reported. In Britain, the Medical Devices Agency issued an advisory warning in November 1999 about a "high rate of early thromboembolic complications," including stroke.

Peter Gove says media reports that his company is resigned to paying out over Silzone are wrong: "We regard the issue as unresolved." He said that product testing complied with international testing standards and the Food and Drug Administration's guidance on heart valves. "To this day, no one really knows what was wrong with the valve."]]> http://www.yourlawyer.com/articles/read/6889 Sun, 24 Aug 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6889
Myrtle McCombe, 44, of Cookstown, Northern Ireland, died on 3 July 1998, two months after she had undergone an operation to be implanted with a St Jude Medical mechanical heart valve that had the latest modification of a coat of silver called Silzone.

Two years later her husband Billy received an autopsy report that said his wife had died because of a blood clot that had formed on the metal leaflets of the valve.

In 2000 St Jude Medical recalled all valves that had the coating after sponsoring a huge independent study. The Medical Devices Agency in the UK said the number of people who died shortly after the valve was implanted because of 'thromboembolic events' was unusually high. Around 37,000 valves were distributed worldwide, of which 1,300 were in the UK.

This week, five years after his wife's death, McCombe becomes the first Briton to join about 160 Americans who are taking legal action against St Jude Medical.

'It was months after the valve had been recalled that I found out. I want people who have had valves implanted to go and read their medical records to see if they had Silzone so that doctors can keep a closer eye on them,' McCombe said.

The Department of Health says that the risk associated with the valve mostly occurs shortly after the transplant.

Lawyers claiming negligence against St Jude Medical allege that the testing of the product may have been inadequate.

But a spokesman for the company said: 'Before receiving regulatory approvals, we conducted full and appropriate testing.'

An internal St Jude Medical memo suggests that Europe was used as a testing ground referring to 'the guinea pig continent of Europe.'

'This particular memorandum was prepared by a young sales employee who is no longer with St. Jude Medical,' the spokesman said. ]]> http://www.yourlawyer.com/articles/read/6977 Thu, 17 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6977
Now five years later she finds it difficult to breathe, walk and spend time with her grandchildren.

"It's frustrating. I can't even go up the stairs and carry a glass of water in my hand," she told CBC News.

She is one of a handful of Canadians who claim they received faulty mechanical heart valves.

They are now trying to win the right to launch a class action lawsuit against the manufacturer, St. Jude Medical Inc.

In the late 1990s, surgeons implanted about 2,000 patients across the country with silzone mechanical heart valves made by St. Jude.

The company removed the product from the market about four years ago amid safety concerns that the valve's silver coating intended to reduce heart infections may cause the valve to leak.

Now the company is facing fresh allegations that it withheld important information from regulatory authorities such as Health Canada.

The lawyers filing for class action status allege the company never told Health Canada that a sheep had died after receiving one of the valves.

If the suit is approved, lawyers for the plaintiffs are vowing to prove St. Jude acted irresponsibly. ]]> http://www.yourlawyer.com/articles/read/6918 Tue, 01 Apr 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6918
Two devices have come under scrutiny: a heart valve that detaches from the rest of the heart, and a jaw implant that has been linked to brain damage and tumours.

Health Canada doesn't give information on adverse reactions readily available, unlike its counterpart in the United States.

Wendy Simms blames her stroke on a heart valve called Silzone, made by St. Jude Medical of Minnesota.

Health Canada approved the device in 1997 and 2,300 Canadians have had it implanted.

"My valve broke down and my silzone chips were slicing off and looked like little grains of pepper in the tissue around my valve," Simms told CBC Radio.

Dr. Tirone David, a Toronto heart surgeon, says he started to detect problems in a small number of valves they would detach from the rest of the heart. He stopped using them a year before St. Jude Medical pulled it off the market in 2000.

Now the company is facing lawsuits in the U.S. and Canada. The company claims it acted responsibly and complied with Health Canada requirements.

Internal Health Canada documents show the department received little safety information before approving the product.

"Most Canadiansthink Health Canada is protecting them from unsafe devices. This is not the case," says Patrick Orr, an Ottawa lawyer who specializes in government law and regulations.

About 300 Canadians and 25,000 Americans have suffered from problems they way was caused by the implant pain, brain damage, tumours and death.

The suit alleges the implant wasn't properly tested.

Logan's story will appear on CBC TV's Marketplace. The show examines why hundreds of implants from hip and knee replacements, breast enlargers, bone plates to dental hardware require minimal clinical testing, if any, while the number of medical device recalls is on the rise.

Health Canada has not responded to requests for interviews]]> http://www.yourlawyer.com/articles/read/6915 Mon, 05 Aug 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6915
U.S. District Court Judge John Tunheim in Minneapolis will hear arguments Sept. 10 to consider making the individual claims a class-action suit that would include about 11,000 patients who were implanted with St. Jude's Silzone mechanical heart valves. It would also roll up the 89 cases pending in various state courts.

If the case is certified as class action, then it affects not just those people who came forward and filed lawsuits, but every person who has a Silzone valve implanted, said a lawyer, who represents some of the plaintiffs in the case.

"St. Jude is a company that has definitely had an excellent reputation and a serious problem with a product it manufactured. I think it's a significant and serious issue for them," the lawyer said.

Some of the cases involve patients who were not injured but fear that they might be at risk and want St. Jude to pay for follow-up monitoring. Neither side has estimated how much this ongoing monitoring would cost.

St. Jude voluntarily recalled the valves in January 2000 after a company-administered study showed the Silzone coating caused a postoperative complication known as paravalvular leak in about 2 percent of patients vs. a less than 1 percent rate of leakage with a non-Silzone-coated valve. Silzone is a silver coating applied to St. Jude's mechanical heart valves as a way to reduce infections. The suits allege that the leakage forced some patients to undergo further surgery to repair or replace the valve.

St. Jude spokesman Peter Gove declined to be interviewed about the lawsuits. In an e-mailed statement to The Business Journal, he said the company "is vigorously defending against the Silzone claims brought against it."

St. Jude "acted promptly and voluntarily" to recall Silzone heart valve products when it found out there was a problem, he said.

Gove said while it is impossible to predict the outcome of these cases, St. Jude believes that it has adequate product-liability insurance to cover any costs associated with them.

In 2000, St. Jude wrote off $26 million to cover the cost of pulling the Silzone-coated valves from the market.

It remains unknown as to what caused the small, but statistically significant, increase in paravalvular leaks in the patients who had been involved in the study by St. Jude, said Gove. Such leaks are known complications for all heart-valve patients. The normal monitoring that these patients receive should detect any paravalvular leaks; therefore the monitoring sought by the class-action plaintiffs is not medically necessary, he said.

St. Jude continues to stress the importance of the normal diligent monitoring recommended for all patients with mechanical heart valves (regardless of type or manufacturer), and it continues to recommend that clinicians emphasize to patients the importance of keeping scheduled appointments and of reporting all changes in symptoms, Gove said.

The company has established a Medical Expense Reimbursement Program (MERP), Gove said. This program reimburses any out-of-pocket expenses not otherwise covered by the patients' insurance that are medically necessary and associated with the treatment and detection of paravalvular leak. St. Jude Medical also maintains a Silzone hotline for patients or physicians who may have questions about these products, he said.

Unlike when your car gets recalled, and you just have to stop in a garage and have a leaky radiator or some other part replaced, recalling heart valves involves major surgery. "Obviously you prefer not to expose someone to further surgery if there's no need at the moment," said Steven Angstreich, an attorney from Cherry Hill, N.J., who is representing the plaintiffs in the federal lawsuits along with Rudd.

A lawyer who represents Lester Grovatt, a South Jersey, N.J., man who was implanted with a St. Jude valve that had the Silzone coating.

"He had numerous problems and then learned to his dismay that it was a Silzone valve that was being recalled," Grovatt's lawyer said. "He was very upset by it ... and he's very troubled by the fact that he has to live with what he fears to be a defective product in him."

The Silzone case is small by comparison to many class-action suits, said Jodine Mayberry, managing editor of Medical Devices Litigation Reporter out of Wayne, Penn., which follows product-liability litigation. There are some cases with 500 or 600 plaintiffs active right now, Mayberry said. And the Silzone case doesn't come close to measuring up to the asbestos or breast implant cases that involved thousands of plaintiffs and multiple defendants for years, she said.]]> http://www.yourlawyer.com/articles/read/6914 Mon, 08 May 2000 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6914 ]]> http://www.yourlawyer.com/articles/read/6890 Mon, 24 Jan 2000 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6890
This recall does not affect St. Jude Medical products without the Silzone coating.

St. Jude Medical has received information which indicates a statistically significant higher rate of paravalvular leak leading to valve explants in patients implanted with St. Jude Medical mechanical heart valves with Silzone coated sewing cuffs.

St. Jude Medical is asking suppliers to discontinue the use of Silzone coated products immediately. In addition suppliers should immediately inspect their inventory for any Silzone products and quarantine them.

]]> http://www.yourlawyer.com/articles/read/6916 Mon, 24 Jan 2000 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6916
St. Jude Medical Inc. of Minnesota recalled inventories of St. Jude's heart valves with Silzone coating that have not yet been implanted into patients.

Valves already implanted and the St. Jude's valves that do not contain the silver coating were not recalled. St. Jude Medical said the incidence of leakage was not high enough to require the valves be explanted (removed) from patients not experiencing trouble.

About one per cent of all heart valves leak, while the incidence with silver-coated valves appears to be about two per cent.

The valves were coated with silver because the metal can have antibiotic properties, which could help lead to fewer heart infections, a serious risk for all heart valve recipients.

About 36,000 of the silver-coated valves have been implanted into patients worldwide. About 2,000 have been distributed in Canada. ]]> http://www.yourlawyer.com/articles/read/6919 Wed, 24 Feb 1999 00:00:00 -0800 http://www.yourlawyer.com/articles/read/6919
Christine Krizin, 53, had a valve surgically inserted in her heart at Resurrection Medical Center on April 17, 1999, because she suffered from a heart condition. She died nine days later.

"She could have lived the rest of her life normally, if everything [had gone] okay with the valve," said an attorney for the Krizin family.

He said the device caused paravalvular leaks, which occur when blood seeps around the outside of the implanted valve, between it and the heart tissue.

The leakage caused Krizin's death, Baker said.

The lawsuit, filed Wednesday in Cook County Circuit Court, states that St. Jude Medical, Inc., a St. Paul, Minn.-based medical supply company, designed, produced and sold a dangerous product.

In January, the company voluntarily recalled all valves that were coated with a substance called Silzone, a type of silver.

The recall "has nothing to do with the operation of the valve mechanism," according to Peter Gove, a spokesman for St Jude Medical.

He said the recall came after the company did a clinical trial of valves with the Silzone coating and found that "leakage occurred at a higher rate with Silzone [coated valves]."

In Krizin's case, the valve's sewing cuff a polyester fabric used to stitch the valve into the heart was coated with Silzone, according to the lawsuit.

Gove said the company first introduced Silzone in 1997 to reduce infections in valve procedures.]]> http://www.yourlawyer.com/topics/overview/st_jude_aortic_connector Wed, 24 Feb 1999 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/st_jude_aortic_connector St. Jude Symmetry Bypass Aortic Connector The St. Jude Symmetry Bypass Aortic Connector has been associated with a high occurrence of heart attacks, respiratory failure, and has been linked several deaths. The adverse effects associated with the St. Jude Symmetry Aortic connector include graft narrowing, valve leakage, failed deployment, and occlusion.

The St. Jude Symmetry is commonly used in "beating heart" or "off machine" heart bypass surgery. "Beating Heart" or "Off Machine" bypass surgery has become increasingly popular because it eliminates the need for the bypass patient to hooked up to a lung machine during bypass surgery. The device allows thoracic surgeons to attach saphenous (leg) vein grafts to the aorta without sutures and without clamping the aorta during the procedure.

The St. Jude Medical Symmetry device was approved in 2001 after an abbreviated approval process. There have been thousands of the devices implanted during coronary bypass surgery, mostly in "off pump" or "beating heart" procedures where surgeons do not place the patient on the heart lung machine.

Despite adverse reports, the manufacturer of the symmetric bypass aortic connectors, St. Jude Medical neither conducted clinical trials or testing of a larger segment of the post-cardiac bypass population, nor have they made any alterations in design or manufacture that would lessen the great danger the aortic connector poses to implant patients.

To make matters worse, St. Jude Medical has not contacted the physicians or patients to emphasize the importance of regular monitoring and testing of patients with the Symmetry connector. The Symmetry Bypass Aortic connector is still on the market and aggressively marketed by St. Jude Medical.

If you or a loved one suffered injuries from a St Jude Aortic connector, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>